Systems and methods for managing and analyzing data generated by an implantable device

ABSTRACT

A system is provided including an implantable device configured to be implanted subcutaneously within a patient, a clinician monitoring and control device, an optional patient mobile device, a remote server and/or at least one data analyst device used by a data analyst. The implantable device may communicate with any or all of the monitoring and control device, the mobile device and/or the remote server through the charging device or by establishing a direct wireless connection with each such device. The data analyst device may establish a direct connection with the remote server and also may establish a connection with the monitoring and control device and the mobile device. By analyzing and reviewing the data generated by the implantable device, the data analyst may diagnose a medical condition or indicate a heightened risk of a condition.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/684,479, filed Aug. 23, 2017, now U.S. Pat. No. 10,769,244, whichclaims the benefit of priority of U.S. Provisional Patent ApplicationSer. No. 62/380,284 filed Aug. 26, 2016, the entire contents of each ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to implantable medical devicesand more specifically to managing and analyzing data generated byimplantable medical devices.

BACKGROUND

Physiological data may offer medical experts an understanding of aperson's wellbeing far beyond what may be gleaned by observation. Forexample, measuring a patient's temperature, pulse, pulse strength,respiratory rate, blood oxygen levels, tidal volume, blood pressure andvarious other physiological parameters may provide medical professionalsa better understanding of the current state of a patient's body, vitalorgans and systems. Physiological data may further include measurementsof biomarkers.

Physiological data also may provide early detection of a medicalcondition. As is the case with many medical conditions, early detectionmay be the difference between life and death. In the field of cancer,periodic monitoring of a patient's wellbeing may improve survival anddecrease mortality by detecting cancer at an early stage when treatmentis more effective. Similarly, early detection of heart disease allowsthe patient to change or eliminate habits that worsen their condition.

Even after a medical condition is detected, physiological data remainsextremely valuable. By monitoring and analyzing a patient's symptoms andphysiological measurements over an appropriate period of time, a betterunderstanding of a patient's wellbeing or medical condition may beachieved. Monitoring a patient's symptoms and physiological measurementsover a period of time will allow physicians and medical professionals tobetter understand the progression of the patient's medical condition anddetect additional related and potentially unrelated conditions. Having arecord of a patient's symptoms and physiological measurements providesan archive from which the significance and relevance of future changesmay be determined.

Though physiological data may be gathered during hospital stays andoffice visits, the data gathered represents only glimpse into thepatient's physiological wellbeing at that given period of time while thepatient is in the hospital or doctor's office. With so few data points,it is difficult to truly understand how these physiological measurementsare changing over time and how they relate to events and routines of apatient. Furthermore, the physiological measurements taken during ahospital stay or doctor's office visit are typically limited tonon-invasive measurement mechanisms limited to the exterior of one'sbody. These types of measurements are often incapable of measuringinterior parameters used as biomarkers such as temperature, pressure andother fluid parameters within a body cavity. Non-invasive measurementslimited to the exterior of one's body typically do not serve as reliablebiomarkers for conditions within the body.

Several devices have been produced that are directed to gatheringspecific physiological data outside of a hospital or doctor's officesetting. Heart rate monitors are an example of a specific physiologicalmeasurement device used outside of the hospital setting. Heart ratemonitors are typically worn by patients who have been diagnosed with aheart condition or have recently had a heart attack. Additionally,athletes are known to wear heart rate monitors for fitness purposes.Typically, heart rate monitors measure the heart rate from the exteriorof the patient's body in a non-invasive manner. Some heart rate monitorsare also capable of communicating to a mobile device allowing the userto view the data at a later time in a reader friendly way.

Similar in purpose is Medtronic's Reveal LINQ Insertable Cardiac Monitordevice which continuously monitors a patient's heart and automaticallydetects and records abnormal heart rhythms. The system is implantedunder the skin in the user's chest and continuously monitors a patient'sheart activity in the form of an electrocardiogram (ECG). When a medicalevent occurs, an extracorporeal recording device is placed in closeproximity to the implantable device to record the heart's rhythm duringthe medical episode.

Another device designed to gather specific physiological data outside ofa hospital or doctor's office setting is Medtronic's Continuous GlucoseMonitoring (CGM) system which measures glucose levels in real time andsends alerts to a remote monitor. The alerts include the directionglucose levels are going, early notification of oncoming lows and highs,alerts for lows or highs, and insights into how food, physical activity,medication, and illness impact glucose levels. The system consists of aglucose sensor inserted under the skin that measures glucose levels, atransmitter that sends the glucose information from the sensor to amonitor via wireless radio frequency, and a small external monitor thatdisplays glucose levels on a screen and notifies the user if it detectsthat glucose is reaching a high or low limit.

While devices for measuring specific physiological parameters outside ofthe hospital or doctor's office setting have been developed andcommercialized, these devices are only directed to measuringphysiological parameters specific to the medical condition being treatedor the part of the anatomy in question. Typically these devices arelimited to one sensor, only measuring heart rate or glucose levels, forexample. For this reason, any analysis of the data generated is oftennarrow in scope and directed to the medical condition being treated.While the limited data generated is helpful for better understandingthat particular medical condition, it offers little to no insight intothe body's overall wellbeing and how other parts of the body or systemswithin the body relate to the medical condition or part of the anatomyin question and therefore is often insufficient to serve as a biomarker.

Another drawback of these devices is that the monitoring or recordingelements of the device are typically physically coupled to the sensingdevice or required to be in very close proximity to the sensing device.Where the sensing device is physically connected to the monitoring orrecording element, this often requires a cable running transcutaneouslyfrom an implanted sensor to an external monitoring or recording device.The transcutaneous cable is not only painful but also could lead toinfection. Additionally, the transcutaneous cable may restrict movementand hinder the user's daily activities.

In U.S. Pat. No. 9,039,652 to Degen, entitled apparatus and methods fortreating intracorporeal fluid accumulation, incorporated by referenceherein in its entirety, an implantable medical sensing device isconfigured to generate data and a charging device is configured todownload the data. The implantable device disclosed in the Degen patentincludes a mechanical gear pump that is configured to be coupled to thebladder and another cavity such as the peritoneal cavity. Theimplantable device in Degen further describes a plurality of sensors tocontinually monitor pressure, temperature, humidity, charge status, pumpstatus, patient movement and other environmental and system relatedparameters. The plurality of sensors may communicate wirelessly with thecharging device only when in close proximity. The charging device maythen relay this information to a physician's computer.

Devices generally require that the monitoring or recording device be inclose proximity to an implantable device. Considering that theimplantable device will frequently be out of range of the monitoring andrecording device, data may not be uploaded to the monitoring orrecording device continuously. Accordingly, the implantable sensingdevice is required to include complex circuitry and memory for storingdata between uploads.

Yet another drawback of these devices is that they often do not generateoperational parameters to track the performance of the implantedmachinery, such as an insulin pump. For example, while a ContinuousGlucose Monitoring system may generate data regarding the patient'sglucose levels, such systems do not measure insulin pump parameters,leaving the performance of the pump in question. Such data, ifavailable, could be compared to the performance of the insulin pump tobetter optimize and understand the pump's effect on the body.

In view of the above-noted drawbacks of previously-known systems, itwould be desirable to provide methods and systems for managing andanalyzing physiological and operational data generated by an implantabledevice using a number of other computing devices not necessarily locatedin close proximity to the implantable device.

SUMMARY

The present disclosure overcomes the drawbacks of the previously-knownsystems having an implantable medical device by providing systems andmethods for managing, reviewing and analyzing data generated by animplantable device configured to communicate wirelessly with a varietyof communication devices including a remote data analyst device.

In accordance with the principles of the present invention, an exemplarysystem may include an implantable device to be implanted into a patient,a charging device for charging and/or communicating with the implantabledevice, a remote server configured to communicate with the implantabledevice and/or the charging device, a monitoring and control device andoptionally, a mobile device, each of which may be in communication withthe implantable device, the charging device, and/or the remote server,as well as each other. The system may further include a data analystdevice in communication with at least the remote server.

The implantable device may have a microprocessor, a communication unit,and a plurality of sensors. The implantable device may generateoperational data and physiological data and extract biomarkers based oninformation sensed by one or more sensors of the plurality of sensors.The operational data and physiological data may be processed using themicroprocessor and communicated to other devices within the system usingthe communication unit. The implantable device may communicate withother devices in the system through communications with the chargingdevice. In this manner, the implantable device may communicateoperational data and/or physiological data to the charging device andthe charging device may then send the data to other devices in thesystem. In this same way, other devices in the system may sendoperational parameters and/or instructions to the implantable device byrelaying that information through the charging device. The communicationunit of the implantable device may communicate with the charging deviceusing any number of well-known wireless communication technologies. Theother devices within the system may communicate with the charging deviceusing any number of well-known wireless or wired communicationtechnologies.

Alternatively, the implantable device may communicate directly to otherdevices within the system, without relaying communications through thecharging device, by communicating wirelessly with these other devices.For example, the monitoring and control device and/or a mobile devicemay receive physiological and/or operational data from the implantabledevice. Wireless communication may be enabled by any number ofwell-known wireless communication technologies. In this manner, theimplantable device may communicate operational data and/or physiologicaldata to the other devices within the system and similarly the otherdevices within the system may wirelessly communicate operationalparameters and/or instructions to the implantable device.

Whether the charging device is used as a relay or the implantable devicecommunicates directly with the other devices in the system usingwireless technology, the remote server may receive physiological and/oroperational data. The data analyst device may access and downloadoperational data and/or physiological data including biomarker data fromthe remote server. The data analyst device may be configured to analyzeoperational and/or physiological data and generate analyst data. Theanalyst data may include trends in the data and may compare theoperational and/or physiological data to past data received from thatindividual's implantable device and/or to data from other implantabledevices. The data also may be compared to predetermined or calculatedthresholds. The analyst data may be communicated to the remote serverand saved on the remote server for retrieval by the charging device, themonitoring and control device and/or the mobile device. The data analystdevice also may generate a warning message containing a medicaldiagnosis or indication of a high risk of a medical condition, forexample, and communicate the warning message to the charging device, themonitoring and control device, and/or the mobile device.

The implantable device also or alternatively may be programmed toanalyze the operational and/or physiological data including biomarkerdata. For example, the implantable device may compare operational and/orphysiological data to predetermined thresholds programmed into theimplantable device. If the operational and/or physiological data exceedsor is otherwise inconsistent with the predetermined threshold, theimplantable device may communicate a warning message to one or more ofthe other devices in the system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary system of the present disclosure havingan implantable device, a charging device, a monitoring and controldevice, a mobile device, a remote server, and data analyst devices.

FIG. 2 is a schematic view of the electronic components of an exemplaryembodiment of the implantable device.

FIG. 3 is a schematic view of the electronic components of an exemplaryembodiment of the charging device.

FIG. 4 is a schematic view of the electronic components of an exemplaryembodiment of the monitoring and control device.

FIG. 5 is a schematic view of the electronic components of an exemplaryembodiment of the mobile device.

FIG. 6 illustrates an exemplary embodiment of a mobile graphic userinterface displayed on the mobile device.

FIG. 7 illustrates a flow chart outlining an exemplary process forgenerating and transmitting a warning of a physiological and/oroperational anomaly.

FIG. 8 illustrates an exemplary embodiment of a warning graphic userinterface displayed on the mobile device.

FIG. 9 illustrates an exemplary embodiment of the physician graphic userinterface displayed on the monitoring and control device.

FIG. 10 illustrates an exemplary embodiment of a communication networkestablished by a monitoring and control device, a remote server and adata analyst devices.

FIG. 11 illustrates an exemplary embodiment of an analyst graphic userinterface displayed on the data analyst device.

DETAILED DESCRIPTION

The system of the present disclosure includes systems and methods formonitoring and analyzing physiological and/or operational data generatedby an implantable medical device. In addition to an implantable device,an exemplary system constructed in accordance with the principles of thepresent invention may include a charging device, a patient's mobilecommunication device, a physician's monitoring and control device, andone or more remote servers. The one or more remote servers further maybe in communication with one or more data analyst devices for accessingthe operational and/or physiological data from the remote server andanalyzing the operational and/or physiological data. The system may beconfigured to alert the physician and/or the patient of a medicalcondition or operational anomaly based on analysis of the physiologicaland/or operational data.

Data generated by implantable medical devices may be analyzed to achieveseveral different objectives, depending on the user group or businessmodel. One goal may be to improve outcomes for patients with chronicdiseases by delivering actionable insights to patients therebyinfluencing their behavior. Another goal may be to reduce healthcarecost and improve quality of life by enabling home care through provisionof safe technical solutions for self-administration and remotemonitoring. Another objective may be to improve outcomes, andpotentially life expectancy, by delivering actionable insights tophysicians based on personalized trend recognition and prediction,enabling early interventions or preventive therapeutical measures. Datagenerated by implantable devices may also deliver actionable insights topharmaceutical companies based on biomarkers.

Data generated by implantable medical devices further ensuresauthenticity as an implantable device with a unique identifier cannoteasily be removed from a patient. The data can be trusted to originatefrom that specific patient unlike wearable sensors which can easily beswapped between patients. Authenticity may be an important factor fornew business models evolving around medical data.

Referring to FIG. 1, an overview of system 10 of the present disclosureis provided. System 10 may include implantable device 15, externalcharging device 40, monitoring and control device 60, mobile device 80and remote server 95 as well as data analyst device 100.

Implantable device 15 is implanted subcutaneously into the body of apatient and is configured to generate various physiological and/oroperational data and communicate physiological and/or operational datato other devices within system 10. As shown in FIG. 1 and discussed inmore detail below, implantable device 15 may have low volume sealedbiocompatible housing 16 which may house a plurality of sensors forgenerating physiological and/or operational data and a transceiver fortransmitting physiological and/or operational data between implantabledevice 15 and other devices within system 10.

Implantable device 15 further may include hardware for treating amedical condition subcutaneously such as a pump. Implantable device 15may include inlet port 17 coupled to inlet catheter 18 and outlet port19 coupled to outlet catheter 20. The pump may be an electromechanicalpump designed to move fluid from one body cavity to another body cavity,e.g. a first body cavity to a second body cavity. For example, theelectromechanical pump may be used for treating ascites by positioninginlet catheter 18 in a patient's peritoneal cavity and outlet catheter20 through the wall of a patient's bladder. In this manner, theelectromechanical pump may move fluid from the peritoneal cavity to thepatient's bladder as disclosed in the Degen patent discussed above. Itis understood that implantable device 15 alternatively or additionallymay be include other hardware within the biocompatible housing.

Referring now to FIG. 2, exemplary functional blocks of implantabledevice 15 are illustrated. In particular, implantable device 15 mayinclude control circuitry, illustratively microprocessor 22 coupled tononvolatile memory 23, such as flash memory or electrically erasableprogrammable read only memory, and volatile memory 24 via data buses.Microprocessor 22 may include firmware having instructions stored onnon-transitory computer readable medium configured to cause transmissionof operational data and/or physiological data to any or all of chargingdevice 40, monitoring and control device 60, mobile device 80 and/orremote server 95. Instructions also may cause implantable device 15 toreceive operational instructions. Microprocessor 22 may be electricallycoupled to battery 25, inductive circuit 26, radio transceiver 27,electric motor 28, infrared LED 38 and a plurality of sensors, includingfor example, one or more humidity sensors 29, one or more temperaturesensors 30, one or more accelerometers 31, one or more pressure sensors32, one or more respiratory rate sensors 33 and one or more heart ratesensors 34. Other sensors additionally could be included in device 15,such as flow rate sensors, ECG sensors, pH sensors, and capacity sensorsfor measuring the amount of a liquid in a given cavity.

Operational data is indicative of the operation of implantable device 15and/or hardware incorporated into implantable device 15 and may begenerated by sensors incorporated into implantable device 15.Physiological data is indicative of the physiological state of thepatient and also may be generated by sensors incorporated into system10. For example, one or more humidity sensors 29 may be used to measurethe humidity within the implantable device housing; one or moretemperature sensors 30 may be used for measuring the temperature in oneor more body cavities (e.g., peritoneal cavity, pleural cavity,pericardial cavity, and/or bladder) or region of the body (e.g.,abdomen) and/or for measuring the temperature within implantable device15 housing and/or the temperature of an implantable device componentsuch as battery 25, one or more accelerometers 31 may be used fordetermining whether the patient is at rest and/or for sensing theposition of a patient, e.g., vertical, horizontal; one or more pressuresensors 32 may be incorporated in implantable device 15 to measure bloodpressure and/or the pressure within one or more body cavities (e.g.,peritoneal cavity, pleural cavity, pericardial cavity, and/or bladder);one or more respiratory rate sensors 33 may be used to sense the numberof breaths taken in a given period of time; and one or more heart ratesensors 34 may be used to sense the rate at which the heart is beatingover a given period of time or the heart rate variation. Other sensorssuch as flow rate sensors, pH sensors and capacity sensors may be usedfor measuring the flow rate of the pump inlet and the pump outlet fromwhich fluid viscosity may also be derived if the flow measurement iscombined with pressure sensor measurements, the acidity of fluids withinthe body, and the degree to which a cavity is filled with fluid,respectively.

Examples of physiological data may include sensed data associated withthe physiology of the patient such as temperature data associated withthe one or more body cavities, accelerometer data associated with, forexample, heart rate, respiratory rate and/or, pressure data associatedwith blood pressure and/or the one or more body cavities, respiratoryrate data, and heart rate data, flow rate data associated with the oneor more body cavities, pH data associated with bodily fluid pumped bythe implantable device, and capacity data associated with the one ormore body cavities. Physiological data may include biomarkerdata—measurable data indicative of a biological state or condition. Forexample, the viscosity of ascites in patients with liver disease may actas a biomarker indicative of an infection. Data gathered from multiplesensors within the patient may be combined to result in an effectivebiomarker. For example, temperature data in combination with ascitesviscosity data may be combined to result an even more reliable indicatorof an existing or developing infection. Examples of operational data mayinclude data associated with the implantable device such as humiditydata associated with the implantable device, temperature data associatedwith the implantable device, pressure data associated with theimplantable device, flow rate data associated with the implantabledevice and may also include data related to the pump such as RPM data,efficiency data, run-time data, etc. In some cases, operationalparameters may even serve as an indirect measurement of physiologicalparameters. For example, measurement of the motor torque of a pump canbe used, in combination with other measured parameters, to determinefluid viscosity based on flow resistance.

Inductive circuit 26 may be electrically coupled to coil 35 to receiveenergy transmitted from charging device 40. Transceiver 27 mayincorporate wireless communication unit 37 and may be coupled to antenna36. Wireless communication unit 37 may be communication circuitry, suchas a chipset, conforming to one or more wireless telephony/cellularstandards such as GSM, LTE, CDMA, and/or other communication standardssuch as BLUETOOTH™, Bluetooth low energy, ZigBee, IEEE802.15, NFC, anyIEEE 802.11 wireless standard such as Wi-Fi or Wi-Fi Direct or any otherwireless standard comprising optical, acoustical or conductiveintracorporal principles. All of the components depicted in FIG. 2 maybe contained within housing 21, as shown in FIG. 1.

As shown in FIG. 1, charging device 40 may be a hand held device andhaving an ergonomic housing suitable for being held. As discussed inmore detail, charging device 40 may transcutaneously transfer energyusing inductive coils in the respective devices to charge battery 25 inimplantable device 15. Charging device 40 also may be in directcommunication with implantable device 15 using transceivers andcommunication units in each device. Charging device 40 may includenon-transitory computer readable medium and instructions run on thenon-transitory computer readable medium that permits communication withimplantable device 15 including transmission of data to implantabledevice 15. The instructions also may permit charging device 40 toreceive data from implantable device, monitoring and control device 60,mobile device 80 and data analyst device 100. Charging device 40 maycommunicate to implantable device 15 operational instructions, includingat least operational parameters, and may receive from implantable device15 physiological and/or operational data. Operational instructions maycontrol the operation of implantable device 15 and hardware incorporatedinto implantable device 15. For example, operational instructions mayinstruct hardware incorporated into implantable device 15 to operate atspecified operational parameters or settings. Operational parameters orsettings may include pump displacement settings, pump voltage or currentsettings, pump flow rate settings, pump RPMs, or any other settings atwhich hardware incorporated into pump may be set to operate at. Chargingdevice 40 may receive and store the physiological and/or operationaldata received from implantable device 15. Charging device 40 may furtherbe in communication with other devices in system 10 such as monitoringand control device 60, mobile device 80 and remote server 95.

Referring now to FIG. 3, a schematic diagram of exemplary functionalblocks of charging device 40 is described. Charging device 40 mayinclude microprocessor 41 coupled to nonvolatile memory 42 (e.g., eitherEEPROM or flash memory), volatile memory 43, radio transceiver 44,inductive circuit 45, battery 46, indicator 47 and display 48.Microprocessor 41, non-volatile memory 42 and volatile memory 43, andradio transceiver 44 may be incorporated into a single unit, such as theMPS430 family of microprocessors, available from Texas InstrumentsIncorporated, Dallas, Tex. Transceiver 44 may be coupled to antenna 49for sending and receiving information to and from implantable device 15.Transceiver 44 of charging device 40 may include wireless communicationunit 50, that may be communication circuitry, such as a chipset, thatconforms to one or more wireless telephony/cellular, BLUETOOTH™,Bluetooth low energy, ZigBee, IEEE 802.15, NFC, IEEE 802.11 wirelessstandards or any other wireless standard comprising optical, acousticalor conductive intracorporal principles, thereby enabling charging device40 to communicate wirelessly with one or more of implantable device 15,monitoring and control system 60, mobile device 80 and remote server 95.It is further understood that wireless communication unit 50 may becompatible with more than one type of communication standard. Battery 46may be coupled to connector 51 to charge battery 46 using an externalpower source. Input device 52, preferably a multi-function button, alsomay be coupled to microprocessor 41 to enable a patient to input anumber of commands into charging device 40. Indicator 47 may comprise aplurality of LEDs that illuminate to indicate the quality of chargeachieved between charging device 40 and implantable device 15, andtherefore assist in optimizing the positioning of charging device 40relative to implantable device 15 during recharging.

Microprocessor 41 also may execute firmware stored in nonvolatile memory42 that controls communications and/or charging of the implantabledevice. Microprocessor 41 is configured to transfer and store data, suchas physiological data, operational data, and/or event logs, uploaded tocharging device 40 from implantable device 15. Microprocessor 41 mayinclude firmware having instructions stored on non-transitory computerreadable medium configured for receiving command inputs from monitoringcontrol device 60 and/or mobile device 80 and for transmitting thosecommand inputs to implantable device 15. Microprocessor 41 also mayinclude firmware having instructions stored on non-transitory computerreadable medium configured for transmitting command inputs toimplantable device 15 using input device 52 incorporated into chargingdevice 40. Microprocessor 41 also may include firmware havinginstructions stored on non-transitory computer readable mediumconfigured to cause transmission of operational data and/orphysiological data to remote server 95. The instructions also may causecommunication unit 50 of charging device 40 to communicate with remoteserver 95 over the internet and/or over via a wireless telephony regime.Furthermore, the instructions may cause the communications betweenremote server 95 and charging device 40 to be encrypted. Microprocessor41 may also control and monitor various power operations of chargingdevice 40, including operation of inductive circuit 45 during rechargingof the implantable device and displaying the state of the charge, e.g.the charge rate or percentage charged.

Inductive circuit 45 is coupled to coil 53, and is configured toinductively couple with coil 35 of implantable device 15 to rechargebattery 25 of implantable device 15. Energy transfer is accomplished viaelectromagnetic coupling of coil 53 with coil 35 in the implantabledevice. As will be appreciated by one of ordinary skill, an alternatingcurrent may be delivered through coil 53, which causes anelectromagnetic field to be established around coil 53, which induces analternating current in coil 35 when coil 53 and 35 are held in closeproximity.

Monitoring and control device 60, shown in FIG. 1, may be a clinician orphysician computer used by the clinician or physician to, among otherthings, set and adjust operational parameters and download event logs aswell as retrieve and display physiological and/or operational datagenerated by implantable device 15 as well analyst data generated byanalyst device 65. Monitoring and control device 60 may be any computingdevice (e.g., personal computer, laptop, tablet, smartphone, etc.) ofthe clinician and is illustratively a laptop computer. Using monitoringand control device 60, a clinician may review data generated byimplantable device 15 and track a patient's health in addition to theperformance of hardware incorporated into implantable device 15. Aclinician or physician using monitoring and control device 60 may alsoreceive actionable insight and administer treatment or otherwiseeffectuate changes to improve the patient's condition or wellbeing.

Referring now to FIG. 4, a schematic diagram of exemplary functionalblocks of monitoring and control device 60 is described. Monitoring andcontrol device 60 preferably includes components generally found on aconventional personal computing device, such as processor 61, volatileand/or non-volatile memory 62, user interface 63 such as digitaldisplay, input and output components 64 including, for example, akeyboard, a mouse and a USB port, transceiver 65, a power supply port66, and a battery 67. Transceiver 65 may include wireless communicationcircuitry conforming to one or more of cellular, BLUETOOTH™, Bluetoothlow energy and ZigBee standards, IEEE 802.15, NFC or any IEEE 802.11wireless standard such as Wi-Fi or Wi-Fi Direct. Furthermore, monitoringand control device 60 may include software 68 that, when run onprocessor 61, retrieves and displays physiological and/or operationaldata and, when run on monitoring and control device 60, causesmonitoring and control device 60 to communicate operationalinstructions, including operational parameters, to implantable device 15and/or charging device 40. The physiological and/or operational data maybe transmitted to monitoring and control device 60 from implantabledevice 15, charging device 40, remote server 95, and/or data analystdevice 100.

As shown in FIG. 1, optional mobile device 80 also may be incorporatedin system 10. Mobile device 80 may be a patient mobile communicationdevice and may be used by the patient or a person assisting the patientto, among other things, view physiological and/or operational data.Mobile device 80 may be any mobile communication device (e.g.,smartphone, tablet, smartwatch, laptop, etc.) of theuser/patient/caregiver and is illustratively a smartphone having a largedisplay. As discussed in more detail below, using mobile device 80, thepatient may communicate with implantable device 15, charging device 40,and/or monitoring and control device 60.

Referring now to FIG. 5, a schematic diagram of exemplary functionalblocks of mobile device 80 is described. Mobile device 80 may includecomponents generally found on any modern mobile device such as processor81, volatile and/or non-volatile memory 82, user interface 83 such asdigital display, input and output mechanisms 84 including, for example,a keyboard, touchscreen or a USB port, transceiver 85, power supply port86, and battery 87. Transceiver 85 may include a wireless communicationcircuitry conforming to one or more of cellular standards such as GSM,LTE, CDMA or other communication standards such as BLUETOOTH™, Bluetoothlow energy, ZigBee, NFC, any IEEE 802.11 wireless standard such as Wi-Fior Wi-Fi Direct. For example, transceiver 85 may conform to a cellularstandard having SMS text and voice message capability. Furthermore,mobile device 80 may include software 88 having instructions stored onnon-transitory computer readable medium that, when run on processor 81,causes mobile device 80 to communicate with implantable device 15 and/orremote server 95 to retrieve and display physiological data, operationaldata, and/or analyst data. Software 88 may further be configured togenerate instructions that, when run by processor 81, cause mobiledevice 80 to communicate operational instructions to implantable device15 and charging device 40.

Remote server 95, as shown in FIG. 1, may receive physiological and/oroperational data generated by implantable device 15 and may store thephysiological and/or operational data. Remote server 95 may be accessedfor retrieval of the physiological and/or operational data as well asany other data generated by implantable device 15 or by other devicessuch as mobile device 80, monitoring and control device 60, and/or dataanalyst device 100. Remote server 95 may communicate with other devicesin system 10 using any of the known methods of communication discussedabove. For example, remote server 95 preferably is connected to theInternet to communicate with any or all of charging device 40,monitoring and control device 60, mobile device 80, and/or data analystdevice 100.

Data analyst device 100, also shown in FIG. 1, may be used by a dataanalyst to compile, review and analyze the data generated by implantabledevice 15 and generate data analysis based on the data generated byimplantable device 15. Data analyst device 100 may include a computerreadable medium and instructions stored on the computer readable mediumand run on data analyst device that cause the data analyst device tocommunicate with remote server 95 to receive from remote server 95operational data and/or physiological data. Additionally, theinstructions may cause data analyst device 100 to compile theoperational and/or physiological data and generate analyst data. Theinstructions may also cause data analyst device 100 to communicate withremote server 95 to transmit analyst data to remote server 95. Dataanalyst device 100 may make a wired connection with remote server 95 viaany suitable LAN or WAN or may communicate wirelessly with remote server95. Using data analyst device 100, the data analysis generated by dataanalyst device 100 may be transmitted to the remote server 95 and storedon remote server 95 for retrieval by monitoring and control device 60and/or mobile device 80.

Data analyst device 100 may be any computing device (e.g., personalcomputer, laptop, tablet, smartphones, etc.) of the data analystconfigured to retrieve physiological and/or operational data and analyzethe data for trends and anomalies. The instructions also may cause dataanalyst device to generate analyst data or aid the data analyst in thegeneration of analyst data which may include a diagnosis a medicalcondition and/or an indication a heightened risk of a medical condition.The instructions run on the non-transitory computer readable medium maycause data analyst device 100 to generate a warning message when theoperational data and/or physiological data exceeds preprogrammedthresholds and also may cause data analyst device 100 to communicate thewarning message to the patient mobile communication device 80 and/ormonitoring and control device 60. Data analyst device 100 may includecomponents generally found on a conventional personal computing device,such as a processor, volatile and/or non-volatile memory, a userinterface such as digital display, a transceiver, a battery and inputand output components such as a keyboard, a mouse and a USB port.

There are at least two ways in which implantable device 15 maycommunicate with system 10. First, implantable device 15 may be indirect wireless communication with charging device 40 using one or moreof any well-known wireless standards such as GSM, LTE, CDMA, BLUETOOTH™,Bluetooth low energy, ZigBee, NFC, or any IEEE 802.11 wireless standardsuch as Wi-Fi or Wi-Fi Direct or any other wireless standard comprisingoptical, acoustical or conductive intracorporal principles. In thisfirst configuration, implantable device 15 may communicate with otherdevices in system 10 by relaying communication through charging device40. Charging device 40 may be in either wired or wireless communicationwith one or more of the devices in system 10 using one or morewell-known communication standards including but not limited to GSM,LTE, CDMA, BLUETOOTH™, Bluetooth low energy, ZigBee and any IEEE 802.11wireless standard such as Wi-Fi or Wi-Fi Direct. For example, chargingdevice 40 may connect with implantable device 15 using Wi-Fi Direct andalso may make a connection with a local Wi-Fi router and connect to theinternet. Through the Internet, charging device 40 may be incommunication with monitoring and control device 60, mobile device 80,and/or remote server 95.

Charging device 40, monitoring and control device 60 and mobile device80 may each be configured to run instructions stored on a non-transitorycomputer readable medium programmed with messaging protocols that allowseach device to communicate to one another over the internet. Commandsmay be communicated to microprocessor 41 of charging device 40 frommonitoring and control device 60 and/or mobile device 80 which maysubsequently be relayed from charging device 40 to implantable device15. In this manner, communicating with charging device 40 through themonitoring and control device 60, a clinician may communicate withimplantable device 15 to set or adjust the operational parameters ofimplantable device 15. Upon receiving the command to set or adjust theoperational parameters, implantable device 15 will set or adjust theoperational parameters according to the instructions from chargingdevice 40. Alternatively, charging device 40 may communicate with otherdevices within system 10 using different communication standardsdiscussed above.

Where charging device 40 is used as a relay point between implantabledevice 15 and other devices of system 10, information such asphysiological and/or operational data may be communicated fromimplantable device 15 to charging device 40 and then from chargingdevice 40 to remote server 95 for storage on remote server 95. Forexample, implantable device 15 may transmit physiological and/oroperational data to charging device 40. Charging device 40 may store thephysiological and/or operational data and may run a programmed routineconfigured to transmit the stored physiological and/or operational datato remote server 95 for remote storage. The programmed routine mayinclude instructions that permit the charging device to communicate withremote server over the internet or via a wireless telephony regime. Theinstructions also may cause communications from charging device 40 to beencrypted such that transmission of physiological and/or operationaldata is encrypted. Alternatively, charging device 40 may transmit thephysiological and/or operational data to monitoring and control device60 and/or mobile device 80 to be stored on the respective devices. Inthis configuration, monitoring and control device 60 and/or mobiledevice 80 may run a programmed routine configured to transmit the storedphysiological and/or operational data to remote server 95 for remotestorage. The programmed routine further may cause monitoring and controldevice 60 and mobile device 80 to transmit operational parameters andinstructions or commands to charging device 40 to be relayed toimplantable device 15.

The second way in which implantable device 15 may communicate withsystem 10, is by directly communicating with one or more devices insystem 10 without the use of a relay device. In this configuration,communication with other devices within system 10 may be establishedusing any of the communication standards discussed above including closerange standards, such as BLUETOOTH™, Bluetooth low energy, ZigBee andWi-Fi, and long range standards such as GSM, LTE, CDMA. It is furtherunderstood that implantable device 15 may communicate with differentdevices within system 10 using different communication standards asimplantable device 15 may be configured to communicate using more thanone communication standard Like in the first arrangement, where chargingdevice 40 was used as a relay, clinician may communicate withimplantable device 15 to set or adjust the operational parameters ofimplantable device 15. Upon receiving the command to set or adjust theoperational parameters, implantable device 15 will set or adjust theoperational parameters according to the instructions from chargingdevice 40.

For example, implantable device 15 may be in direct wirelesscommunication with monitoring and control device 60 using BLUETOOTH™ orBluetooth low energy connectivity. Monitoring and control device 60 mayinclude non-transitory computer readable medium programmed withinstructions that, when run on monitoring and control device 60 allowsmonitoring and control device 60 to directly communicate withimplantable device 15. In this example, during patient visits, aclinician using monitoring and control device 60 may wirelessly connectto implantable device 15 to download for review, data generated by andstored on implantable device 15. Further, monitoring and control device60 may transmit operational parameters to implantable device 15 toadjust or set operational parameters of implantable device 15 withoutusing charging device 40 as a relay point. Where implantable device 15includes a pump, a clinician may adjust operational parameters in thepump such as timing intervals for running the pump. Upon receiving theoperational parameters, implantable device 15, e.g. the one or moreprocessors, may adjust operation according to the received operationalparameters. While in communication with implantable device 15, theclinician using monitoring and control device 60 also may downloadoperational and/or physiological data stored on implantable device 15.In yet another example, implantable device 15 may support Wi-Ficonnectivity and the clinician using monitoring and control device 60may directly connect to implantable device 15 even when the clinicianand patient are not in the same location.

Implantable device 15 also may be configured to communicate directlywith mobile device 80 and/or remote server 95. Mobile device 80 andremote server 95 may each similarly include a non-transitory computerreadable medium programmed with instructions that, when run on mobiledevice 80 and/or remote server 95 allow mobile device 80 and/or remoteserver 95, respectively, to directly communicate with implantable device15. In this configuration, implantable device 15 may transmit datagenerated from the sensors incorporated in implantable device 15 toremote server 95 so that the sensor data is accessible for review by thedata analyst device 100. Mobile device 80 and/or remote server 95 maycommunicate with implantable device 15 using any of the well-knownmethods discussed above. For example mobile device 80 and remote server95 may have Wi-Fi compatibility and communicate with implantable device20 via the internet. Alternatively, or in addition to, implantabledevice 20 may be configured to have wireless telephony capabilities andestablish a connection to mobile device 80, for example, using LTE.

Whether implantable device 15 uses charging device 40 to communicatewith system 10 or is in direct communication with other devices withinsystem 10, monitoring and control device 60 and/or mobile device 80 mayeach have non-transitory computer readable medium and may each runinstructions on the non-transitory computer readable medium to cause themonitoring and control device 60 and/or mobile device 80 to communicatewith the remote server and receive from the remote server operationaland/or physiological data. Specifically, monitoring and control device60 and/or mobile device 80 may interrogate remote server 95 for new datauploaded onto remote server 95, including data generated by implantabledevice 15 and data generated by data analyst device 100, discussed inmore detail below. For example, monitoring and control device 60 and/ormobile device 80 may be configured to manually interrogate remote server95 to determine if analyst data has been uploaded to remote server 95.

Alternatively, monitoring and control device 60 and/or mobile device 80may each include a non-transitory computer readable medium programmedwith instructions that, when run on monitoring and control device 60and/or mobile device 80, cause monitoring and control device 60 ormobile device 80, respectively, to automatically periodicallyinterrogate remote server 95 for new analyst data uploaded to remoteserver 95 to determine, for example, whether uploaded analyst dataincludes a diagnosis of a medical condition and/or an indication of ahigh risk of a medical condition. Monitoring and control device 60 maybe configured to transmit an alert to mobile device 80 upon confirmationthat the analyst data includes a diagnosis of a medical condition and/oran indication of high risk of a medical condition. Data analyst device100 and implantable device 15 also may be configured to automaticallygenerate and transmit an alert to monitoring and control device 60and/or mobile device 80 indicating that data has been transmitted to theserver. Preferably communication between implantable device 15, chargingdevice 40, monitoring and control device 60, mobile device 80, remoteserver 95 and/or data analyst device 100 is encrypted.

Referring now to FIG. 6, mobile device 80 may include a non-transitorycomputer readable medium programmed with instructions that, when run,permit mobile device 80 to view data generated by implantable device 15.As shown in FIG. 6, mobile device 80 may be configured to run mobilegraphic user interface 85 for displaying patient identifying information81 and patient data 82 such as physiological and/or operational data. Inthis manner, the patient using the patient mobile device 80 may viewinstantaneous or archived data generated by implantable device 15,allowing the patient to monitor his or her physiological wellbeing atall times. Specifically, mobile graphic user interface 85 may displaydata 83 generated by one or more sensors integrated into implantabledevice 15. For example, mobile graphic user interface 85 may displaytemperature data as well as heart rate, heart rate variation, physicalactivity, respiratory and pressure data generated by the plurality ofsensors.

Mobile graphic user interface 85 also may output parameter status 84.Parameter status 84 may indicate the status of the measured parameter,e.g., whether the measured parameter is LOW, HIGH or OK (normal) for agiven patient. For example, parameter status 84 may indicate to thepatient how the measured parameter compares to pre-programmedthresholds. If the pressure reading exceeds a pre-programmed threshold,the parameter status will read “HIGH”. Similarly, if the pressurereading is below a pre-programmed threshold, the parameter status willread “LOW”. The other parameter statuses in FIG. 6 read “OK” indicatingthat those measurements fall within a normal range between thresholds.

The data displayed on mobile graphic user interface 85 may be receivedfrom remote server 95 when mobile device 80 has established a connectionwith remote server 95. Alternatively, when mobile device 80 hasestablished a direct connection with implantable device 15, the datadisplayed on graphic user interface 85 may be transmitted directly fromimplantable device 15. In yet another example, the data displayed ongraphic user interface 85 may be transmitted from charging device 60.The status parameters illustrated in FIG. 6 may be determined bysoftware run on mobile device 80 or may be included in the data receivedby mobile device 80.

Referring now to FIG. 7, an exemplary test protocol is illustrated,which is run by implantable device 15 to compare measured data topreprogrammed thresholds to determine if a warning should be generated.Test protocol 150 begins with measuring step 151 where the processor ofimplantable device 15 directs at least one of the sensors in implantabledevice 20 to measure physiological and/or operational data.Subsequently, in comparison step 152, the processor executesinstructions to compare the measured data to preprogrammed thresholds.The preprogrammed thresholds may be set or updated from operationalinstructions transmitted to implantable device 15 from other deviceswithin system 10. At decision 153, if the measured physiological and/oroperational data is consistent with the preprogrammed threshold range,the implantable device is instructed to once again measure physiologicalor operational data after waiting a predetermined period of time. If,however, the measured data is outside the preprogrammed threshold range,at warning step 154, the processor executes instructions directingimplantable device 15 to generate a warning message. Upon generation ofa warning message, transmission step 155 executes instructions directingimplantable device 15 to transmit the warning to at least one or more ofmobile device 80, monitoring and control device 60, charging device 40and remote server 95.

Referring now to FIG. 8, mobile device 80 is shown running instructionsstored on a non-transitory computer readable medium that, when run onmobile device 80, causes the mobile device to communicate a warningmessage to the patient/caregiver. As explained above and shown in FIG.7, the warning message may be generated by implantable device 15 andtransmitted either directly from implantable device 15 or relayedthrough charging device 40. Alternatively, the warning may be generatedby the data analyst using data analyst device 100 or monitoring andcontrol device 60 where analysis of the data by the data analyst orclinician revealed a problem or otherwise raised concern. Alternatively,mobile device 80 may analyze physiological and/or operational data bycomparing the physiological and/or operational data to preprogrammedthresholds and/or input physiological and/or operational data intopreprogrammed algorithms and may generate a warning message ifnecessary, e.g., above or below programmed thresholds and/or outside aprogrammed threshold range.

Warning graphic user interface 86 may show actionable insight related tothe measured physiological and/or operational data and may show awarning message related to the physiological and/or operational data.Warning graphic user interface 86 may indicate that an anomaly has beendetected or may even display the measured parameter compared to thepredetermined threshold. For example, analysis from implantable device15 may detect an irregular heartbeat and upon detection, warning graphicuser interface 86 may alert the patient to this anomaly. Warning graphicuser interface 86 may further include a direct link to the patient'sphysician, either by text, email or phone. If it is possible toalleviate the condition by adjusting operational parameters, warninggraphic user interface 86 may seek permission from the patient to adjustthe operational parameters. Where the warning is issued by data analystdevice 100 the warning message also may indicate the type of medicalcondition that has been detected and/or other actionable insightgenerated. Warning graphic user interface 86 may further include a linkto the data related to the warning and/or analysis of the data.Emergency responders may simultaneously be contacted and informed of thepatient's location and condition upon generation of the warning message.

Where the warning is generated by implantable device 15, mobile device80 and/or data analyst device 100, a physician or clinician usingmonitoring and control device 60 may also receive an alert on monitoringand control device 60 regarding the same information displayed onwarning graphic user interface 86. The alert may further include datarelated to the warning, actionable insight and/or a link to access thedata, similar to the warning shown in FIG. 9. Where the warning wasgenerated by implantable device 15 or data analyst device 100, thephysician may then review the parameters in question and if appropriatesend the warning to mobile device 80.

If it is possible to alleviate the condition by adjusting operationalparameters, a request may be sent to the physician or clinician toadjust operational parameters of implantable device 15, and uponreceiving permission, command implantable device 15 to adjust operation,either by communicating the command directly from monitoring and controldevice 60 to the implantable device or relaying the command through thecharging device. Upon receiving the command, implantable device 15 mayadjust the operational parameter or parameters. For example, the commandmay direct the processor of implantable device 15 to pump more or lessfluid from one body cavity, e.g. peritoneal, pleural, pericardial, toanother body cavity, e.g., bladder, peritoneal cavity, and/or to adjusttime intervals between pumping sessions. Implantable device 15 may senda similar alert to any number of devices within the system includingdata analyst device 100. An alert sent to data analyst device 100 fromimplantable device 15 may further include the most recent data measuredby the implantable device relating to the warning being transmitted,allowing the remote analyst to immediately access and analyze therelevant data.

Referring now to FIG. 9, monitoring and control device 60 may runinstructions stored on a non-transitory computer readable mediumprogrammed to permit monitoring and control device 60 to retrieve andview data generated by implantable device 15 and/or data analyst device100. The data received by monitoring and control device 60 on dataanalyst device 100 may provide a clinician or physician actionableinsight, .i.e. may provide the physician enough information to determinehow to act or what measures to take to address a problem or concern. Asshown in FIG. 9, graphic user interface 61 provides a user friendly viewof the data and permits a clinician to receive relevant information in ashort period of time. As explained above, monitoring and control device60 may receive this data from implantable device 15, charging device 40,mobile device 80, remote server 95 and/or data analyst device 100.

Clinician graphic user interface 71 shown in FIG. 9 is illustrative ofan exemplary clinician graphic user interface. As shown in FIG. 9,clinician graphic user interface 61 may include patient identifier 72which may include a record locater such as a patient number and/or thepatient's name. Clinician graphic user interface 60 may, for example,display data arranged into physiological data box 73 and operationaldata box 74. Physiological data box 63 may include current physiologicalmeasurements 75 generated by implantable device 15 as well as averageand/or prior measurements 76 archived by implantable device 15, remoteserver 95, charging device 40 and/or monitoring and control device 60.For example, physiological data box 73 may display physiologicalparameters such as the current respiratory rate, current pressure of abody cavity, current temperature of a body cavity or targeted region ofa body, current heart rate, or any other current measurement sensed byimplantable device 15 indicating the physiological state of the body.Physiological box 73 may also display the physiological parameters suchas average respiratory rate, the average pressure of a body cavity, theaverage temperature of a body cavity or targeted region of a body, theaverage heart rate, heart rate variability over a period of time or anyother average measurement sensed by implantable device 15 indicating thephysiological state of the body, as well as one or more previouslymeasured respiratory rates, previously measured pressures of a bodycavity, previously measured temperatures of a body cavity or targetedregion of a body, previously measured heart rate or any other previouslymeasured parameter sensed by implantable device 15. Illustratively, thecurrent pressure may be 0.55 mmHg while the average pressure may be 0.51mmHg, the current respiratory rate may be 15 breathes per minute whilethe average is 12.5, the current temperature may be 98.8 while theaverage temperature may be 98.7 and the current heart rate may be 68beats per minute while the average heart rate may be 82 beats perminute.

Similarly, operational data box 74 may display operational data such asoperational measurements 77 which may include displacement, temperature,duration and voltage measurements or any other measurements related toperformance of the implantable pump 15 or performance of hardwareincorporated into the implantable pump. Operational data box 74, likephysiological data box 73, may show current operational measurements ofimplantable device 15 or measurements archived by implantable device 15,remote server 95, charging device 40 and/or monitoring and controldevice 60. For example, operational data box 74 may show operationalparameters such as the current measurements for the hardware inimplantable device 15, e.g., current displacement of an incorporatedpump, current temperature of a battery, current flow speed, currentvoltage measurements, or any other current measurement sensed byimplantable device 15 indicative of the operation of implantable device15 or hardware incorporated in implantable device 15.

Operational box 74 also or alternatively may show operational parameterssuch as average displacement or a previously recorded displacementmeasurements, average temperature or a previously recorded temperaturemeasurements, average flow speed or a previously recorded flow speedmeasurements, average voltage or a previously recorded voltagemeasurements or any other average or previously recorded measurementsensed by implantable device 15 indicative of the operation ofimplantable device 15 or hardware incorporated in implantable device 15.Operational data box 74 may further include operational datameasurements such as battery and/or pump temperature, pump RPMs,humidity within the housing of implantable device 15, or any othermeasurements related to the performance or operation of implantabledevice 15 or hardware incorporated into implantable device 15.

Clinician graphic user interface 71 may also show other parameters anddata amounting to actionable insight. For example, clinician graphicuser interface 71 may include parameters calculated from measuredphysiological and/or operational parameters such as viscosity of a fluidwithin a body cavity or burn rate of calories. Actionable insightgarnered from measured physiological and/or operational parameters maybe generated using algorithms programmed into implantable device 15,monitoring and control device 60, mobile device 80, or data analystdevice 100. Alternatively, or in addition to, a data analyst may analyzemeasured physiological and/or operational parameters on data analystdevice 100 and generate actionable insight by comparing data to knowntrends or correlations.

Using clinician graphic user interface 71, a clinician or physician mayadjust the performance of implantable device 15 by altering operationalsettings which may also appear in operational data box 74. For example,a clinician may change the desired displacement of the pump to 0.05.This change may be immediately communicated to implantable device 15either through direct communication between implantable device 15 andmonitoring and control device 60 or by using charging device 40 as arelay. Other examples of settings that a clinician or physician mayadjust include the timing of pump activation, duration of pumping, orany other setting that may control the operation of implantable device15 or hardware incorporated into implantable device 15.

Physician graphic user interface 71 may be customizable such that thephysician may decide which data to display. The physician may choose todisplay any combination of archived data and current data. For example,the physician may customize the graphic user interface to displaypressure averages over a period of time, e.g., the last six months, ormay choose to display pressure highs and lows instead. Alternatively, aphysician may customize the graphic user interface to only show selectphysiological and/or operational data but not others, e.g., thepressure, temperature and heart rate, but not the respiratory rate.

Clinician graphic user interface 71 also may generate one or moregraphic representations of the data generated by implantable device 15.Graphic representation 78 may be generated by the physician to analyze agiven parameter over a certain period of time. Graphic presentation 78may include a flow chart(s), a pie chart(s), a bar graph(s), etc.,representing measured physiological and/or operational data. Thephysician may choose to compare the patient's respiratory rate againstthe patient's heart rate for a given period of time to better understandthe patient's oxygen saturation levels. As is discussed in more detailbelow, graphical analysis also may be generated by a dedicated analystremotely and may be viewed by the clinician on graphic user interface71. Similarly, tables and various other well-known data comparisonmethods may be generated remotely by dedicated analysts at data analystdevices and accessed by the clinician using graphic user interface 71.Clinician graphic user interface 71 may display additional informationsuch as that shown in U.S. Pat. No. 9,039,652 to Degen, the entirecontents of which are incorporated herein by reference.

Clinician graphic user interface 71 also may communicate variousmessages such as warnings 79 to the physician. Warnings or alerts may begenerated by implantable device 15, mobile device 80 and/or data analystdevice 100. For example, where implantable device 15 has a pump,clinician graphic user interface 71 may display a warning that the pumpexperienced a malfunction such as a clog and may even suggest methodsfor fixing the problem such as reversing flow direction. In anotherexample, monitoring and control device 60 may run instructions stored ona non-transitory computer readable medium programmed to automaticallycompare physiological parameters and/or operational parameters againstpredetermined thresholds and to automatically generate a warning when ananomaly is discovered, e.g. when the measured parameters are above orbelow predetermined thresholds and/or are outside of a predeterminedthreshold range(s), much like the process shown in steps 152 to 155 inFIG. 7.

Clinician graphic user interface 71 may support a messaging protocolestablished on monitoring and control device 60 and/or mobile device 80.The messaging protocol may permit a physician or clinician tocommunicate a message and/or a warning to the patient by transmittingthe message and/or warning to mobile device 80. For example, a physicianmay notice an unusual physiological and/or operational parameter ortrend and may send a message to mobile device 80 to, for example, askthe patient how he or she feels or if he or she is experiencing certainsymptoms or discomfort. Using the messaging protocol, the patient mayinform the physician of his current condition using mobile device 80. Ifthe physician instead notices from the physiological data that thepatient is currently experiencing a medical event or is about toexperience a medical event, the physician may immediately message thepatient with instructions on what to do next. For example, the messagemay direct the patient to immediately cease all physical activity.Alternatively or additionally, the physician may message emergencyservices using clinician graphic user interface 71 and inform emergencyservices of the patient's location and condition.

Referring now to FIG. 10, implantable device 15 optionally may be indirect wireless communication with remote server 95 via a LAN or WAN orcommunicate with remote server 95 additionally via charging device 40.Remote server 95 is also in communication with one or more data analystdevices 100 via a hard connection or wireless connection. One or moredata analyst devices 100 also may be in communication with one anothereither wirelessly or by wired connection. An analyst using data analystdevice 100 may periodically access, download and review on data analystdevice 100, operational and/or physiological data received by remoteserver 95. Though data analyst device 100 may be in a different city oreven a different country than implantable device 15, the analyst mayaccess recently generated data from implantable device 15 via the remoteserver. In addition to receiving and accessing data from remote server95, data analyst device 100 may transmit analyst data to remote server95. Remote server 95 may store the data transmitted from data analystdevices 100 for retrieval by other devices such as mobile device 80and/or monitoring and control device 60.

Data analyst device 100 also may establish a connection with otherdevices within the system and retrieve physiological and/or operationaldata for the other devices. For example, a remote analyst using dataanalyst device 100 may retrieve physiological data from implantabledevice 15, analyze the received physiological data, and transmit dataanalysis to a remote server 95 for download by other devices in thesystem. As another example, a remote analyst using data analyst device100 may retrieve operational data from implantable device 15, analyzethe received operational data, and transmit data analysis to a remoteserver 95 for download by other devices in the system. As explainedabove, the data analysis may include actionable insight that may providea patient, caretaker, physician or clinician enough information todetermine how to act or what measures to take to address a problem orconcern.

Referring now to FIG. 11, analyst graphic user interface 101 is showndisplayed on data analyst device 95. Analyst graphic user interface 101may include patient identifier 102 which may include a record locatersuch as a patient identification number and/or the patient's name.Analyst graphic user interface 101 also may include data analystidentifier 103 that indicates the data analyst that generated theanalysis. Analyst graphic user interface 101 is used to present the dataanalyst with an easy to understand representation of select datagenerated by implantable device 15 such as operational and/orphysiological data. Analyst graphic user interface 101 may be completelycustomizable by the analyst to meet the analyst's needs and analyticalapproach. For example, analyst graphic user interface 101 may displaydata in a table format and/or a graphical format or in any otherwell-known format known for data analysis.

Using analyst graphic user interface 101, data analyst may review andanalyze data, e.g., operational and/or physiological data generated byimplantable device 15. Analyst also may use both current data andarchived data to observe trends, predict trends, identify a medicalcondition and/or risk of a medical condition and produce actionableinsight. Data from multiple patients may be anonymously ornon-anonymously compared against each other. For example, data generatedfrom a son's implantable device may be compared to data generated by afather's implantable device to better understand the effects of ahereditary condition where both patients have the same diagnosis.Alternatively, data from multiple patients known to have developed thesame condition may be collectively analyzed to search for a trend amongthe data. Such a trend may help prevent or diagnose the medicalcondition in others who share the same trend.

In an exemplary embodiment, a data analyst may detect early warningsigns of a heart attack by analyzing data generated by respiratory ratesensors, heart rate sensors, ECG sensors, blood pressure sensors, and/ortemperature sensors. The data generated from these sensors may becompared to trends of individuals who have had heart attacks todetermine whether a heart attack is imminent or likely. Similarly, usingsensors including respiratory rate sensors, heart rate sensors, bloodpressure sensors and/or temperature sensors, a data analyst may detectearly signs of heart failure.

Specifically, from the respiratory rate sensor, shortness of breath maybe detected in addition to chronic coughing or wheezing; from the bloodpressure sensor, high blood pressure may be detected; from thetemperature sensor, abnormalities in the patient's temperature may bedetected; and from the heart rate sensor, an increased heart rate may bedetected. Additionally, a third heart sound known as ventricular gallopor a protodiastolic gallop may also be detected which is an additionalindicator of heart failure. Data analyst device 100 may run instructionsstored on a non-transitory computer readable medium programmed toautomatically compare data generated by implantable device 15 to varioustrends to determine the risk of a given condition or medical event. If arisk of a medical condition or event is determined to be high, theinstructions may also generate a warning of the risk and automaticallystore the warning on remote server 95 for retrieval by mobile device 80and/or monitoring and control device 60 and/or may automaticallytransmit the warning to mobile device 80 and/or monitoring and controldevice 60.

Analyst graphic user interface 101 shown in FIG. 11 is a snapshotillustrating an exemplary embodiment of an analyst's graphic userinterface. As shown, analyst graphic user interface 101 maysimultaneously display multiple graphical representations of data forcomparison. For example, analyst graphic user interface 101 may displaygraphical representations of a measured pressure 104, over a period oftime. Similarly, graphic user interface 101 also may display a graphicalrepresentation of the measured heart rate 105 over the same period oftime. By comparing the measured pressure and the measured heart rate onoverlaid graphical representation 106, an analyst may make immediateinferences and conclusions about the relationship between the twoparameters. In this example, it is clear from the overlaid graphicalrepresentation that the measured pressure and measured heart rate spikedon the same day, April 16^(th).

Analyst also may wish to compare certain data to archived data bygenerating a table. One or more tables may display one or more measuredparameters from implantable device 15 over time including selectmeasurements such as highs or lows over a time period. For example,table 107 illustrates the highest pressure measurement and the highestheart rate measurement for each month. In the snapshot shown, for themonth of April, the highest pressure measured is 1.25 mmHg and thehighest heart rate measured is 113 beats per minute. Analyst graphicuser interface 101, arranged in the manner shown, allows the analyst tocompare table 107 to graphic representations 104, 105 and 106. It isunderstood that an analyst may use any number of analytic tools that arewell known in the art for analyzing the data generated by theimplantable device.

The data analysis generated by data analyst device 100 may be formattedin any number of well-known ways and transmitted to and stored on remoteserver 95. For example, the results may be in the form of a report or aspreadsheet. Alternatively, the analyst may simply save the graphicalrepresentations or tables generated on data analyst device 100 to remoteserver 95. As explained above, in addition to transmitting the dataanalysis to remote server 95, a data analyst using analyst device 100may transmit the results directly to mobile device 80 and monitoring andcontrol device 60 and may generate an alert and communicate the alert tomonitoring and control device 60 and/or mobile device 80 when data hasbeen uploaded to remote server 95.

As discussed above and in accordance with the present disclosure,communication between devices in system 10 may be facilitated by anumber of well-known techniques. While all devices within system 10 maybe in communication with one another, it is understood that some devicesmay be in communication with less than the number of total devices inthe system. For example, some devices of system 10 may be connected tothe internet and others may make one-to-one connections to other devicesthat are connected to the internet using one or more of the well-knownmethods.

While various illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention. For example, system 10 shown in FIG. 1 may include fewercomponents than those shown in FIG. 1 or may alternatively include morecomponents such as more than one monitoring and control device or evenmore than one implantable device. The appended claims are intended tocover all such changes and modifications that fall within the truespirit and scope of the invention.

What is claimed:
 1. A system for managing and reviewing data obtainedfrom an implantable device at a data analyst device, the systemcomprising: an implantable device comprising a housing containing afirst inductive charging circuit, a first microprocessor, a battery, afirst communication unit, a pump configured to move fluid from a firstbody cavity to a second body cavity, and a plurality of sensors, theimplantable device configured to generate operational data andphysiological data; a charging device comprising a second inductivecharging circuit, a second microprocessor, and a second communicationunit, the charging device configured to wirelessly transfer energytranscutaneously from the second inductive circuit to the firstinductive circuit to charge the battery, the charging device programmedto communicate with the implantable device to receive the operationaldata and the physiological data from the implantable device and to storethe operational data and the physiological data on the charging device;and instructions stored on a non-transitory computer readable medium ofthe charging device configured to cause transmission of the operationaldata and the physiological data stored on the charging device to aremote server so that the operational data and the physiological data isperiodically downloaded from the remote server and reviewed at a dataanalyst device.
 2. The system of claim 1, wherein the instructionsstored on the non-transitory computer readable medium of the chargingdevice are configured to cause the charging device to communicate withthe remoter server via the Internet.
 3. The system of claim 1, whereinthe instructions stored on the non-transitory computer readable mediumof the charging device are configured to cause the charging device tocommunicate with the remoter server via a wireless telephony regime. 4.The system of claim 1, wherein the instructions stored on thenon-transitory computer readable medium of the charging device are alsoconfigured to cause transmission of operational instructions, includingat least operational parameters, to the implantable device.
 5. Thesystem of claim 1, wherein the instructions stored on the non-transitorycomputer readable medium of the charging device are configured toencrypt communications between the charging device and the remote serversuch that transmission of the operational data and the physiologicaldata is encrypted.
 6. The system of claim 1, further comprising aclinician computer comprising a non-transitory computer readable mediumand instructions stored on the non-transitory computer readable mediumconfigured to cause the clinician computer to communicate with theremote server and to receive from the remote server the operational dataand the physiological data.
 7. The system of claim 1, further comprisinga patient mobile communication device comprising a non-transitorycomputer readable medium and also comprising instructions stored on thenon-transitory computer readable medium configured to cause the patientmobile communication device to communicate with the remote server and toreceive from the remote server the operational data and thephysiological data.
 8. The system of claim 1, further comprising aclinician computer comprising a non-transitory computer readable mediumand instructions stored on the non-transitory computer readable mediumconfigured to cause transmission of operational instructions, includingat least operational parameters, from the clinician computer to thecharging device.
 9. The system of claim 1, wherein the data analystdevice further comprises a non-transitory computer readable medium andinstructions stored on the non-transitory computer readable mediumconfigured to cause the data analyst device to communicate with theremote server and to receive from the remote server the operational dataand the physiological data.
 10. The system of claim 9, wherein theinstructions stored on the non-transitory computer readable medium ofthe data analyst device are further configured to cause the data analystdevice to compile the operational data and the physiological data,generate analyst data and transmit the analyst data to the remoteserver.
 11. The system of claim 9, wherein the instructions stored onthe non-transitory computer readable medium of the data analyst devicewill cause the data analyst device to generate a warning message whenone or more of the operational data or physiological data exceedspreprogrammed thresholds and communicate the warning message to at leastone or more of the patient mobile communication device and the cliniciancomputer.
 12. The system of claim 1, wherein the plurality of sensorscomprises at least one or more of a heart rate sensor, an ECG sensor, atemperature sensor, or a respiratory sensor and the physiological datacomprises at least one of a heart rate, ECG data, a temperature or arespiratory rate.
 13. A method of managing an implantable devicecomprising: establishing a wireless connection between a cliniciancomputer and an implantable device, the implantable device comprising ahousing containing an inductive charging circuit, a microprocessor, abattery, a communication unit, a pump and one or more sensors; receivingoperational parameters at the implantable device from the cliniciancomputer; adjusting operation of the implantable device according toreceived operational parameters at the implantable device; generatingsensor data from the one or more sensors in the implantable device; andtransmitting the sensor data to a remote server so that the sensor datais accessible for review by a data analyst device.
 14. The method ofclaim 13, further comprising: comparing, at the data analyst device, thesensor data to one or more predetermined threshold ranges; andgenerating, at the data analyst device, an alert if the sensor data isoutside one or more of the predetermined threshold ranges.
 15. Themethod of claim 14, further comprising transmitting the alert from thedata analyst device to at least one or more of the remote server, apatient mobile communication device and the clinician computer.
 16. Themethod of claim 13, further comprising: analyzing, on the data analystdevice, the sensor data accessed from the remote server; generatinganalyst data on the data analyst device based on the sensor data; andtransmitting the analyst data from the data analyst device to the remoteserver.
 17. The method of claim 16, wherein the generating the analystdata on the data analyst device further comprises generating at leastone of a diagnosis of a medical condition, actionable insight and anindication of a heightened risk of a medical condition.
 18. The methodof claim 16, further comprising accessing, using a clinician computer,the analyst data stored on the remote server.
 19. The method of claim17, further comprising periodically interrogating, by the cliniciancomputer, the remote server to determine whether the analyst datacomprises at least one of a diagnosis of a medical condition or anindication of high risk of a medical condition.
 20. The method of claim19, further comprising transmitting an alert to a patient mobilecommunication device, from the clinician computer, upon confirmationthat the analyst data comprises at least one of a diagnosis of a medicalcondition, an indication of high risk of a medical condition or otheractionable insight.